USD Pall Filter Housings for Depth Filter Modules. Stainless Steel Housings designed for the Biopharmaceutical Industry

Transcription

1 USD 5 Pall Filter s for Depth Filter Modules Stainless Steel s designed for the Biopharmaceutical Industry

2 Pall Filter s for Depth Filter Modules Stainless Steel s designed for the Biopharmaceutical Industry Pall Corporation has used design, cost, and industry expectation as the creative foundation of our depth filter technology. In combination with our stringent manufacturing standards, we have developed a comprehensive line of depth filter modules, housings, and capsules for all levels of biopharmaceutical processing. Our depth filter technology is ideal for the following applications: Filtration of fermenter broth Removal of activated carbon Serum filtration Filtration of toxic products Blood plasma fractionation Removal of filter aid and precipitates Separation of mammalian cells Removal of catalysts Process Map for Depth Filtration. LAB SCALE Conduct your filterability trials using our disposable SUPRAcap 60 capsule. It is 6 cm in area and available in double-layer, carbon-impregnated, and pharmaceutical-series media. For more information see Pall publication USD 08 SUPRAcap 60 Depth filtrers. PROCESS DEVELOPMENT Pall SUPRAcap 00 capsules are ideal for process development and small scale production. The capsule is capable of being manifolded in a very small footprint that can process hundreds of liters of process solution. For more information see Pall publication USD 6 SUPRAcap 00 Depth Filter Capusle

3 Veladisc PED Module s Pall depth filter housings enhance the effective filtration of our modules by reducing differential pressure and hold-up volume, while minimizing cleaning costs. Pall applies advanced manufacturing techniques to reduce product contact surface area and minimize the possibility of bacterial retention. Veladisc ASME Module s Veladisc ASME s are non-customizable and low cost, designed in accordance with ASME Section VIII Division. The surface finish, material grade, and speed of manufacture meet or exceed biopharmaceutical industry standards. These housings are intended for process development, small scale, and commercial scale filtration. The ASME Veladisc housing is a standard inventory item for the Western Hemisphere. Please contact your local Pall representative for availability. Pall Advanta s for SUPRAdisc Modules Pall Advanta s for SUPRAdisc Modules were developed for integration into custom-built systems and uniquely large scale applications. The design is derived from a base model validated for clean-in-place, steam-in-place, and full drainability in accordance with ASME BPE-005 and are updated to future addenda. Customized designs include split-dome, skid integration, and housing bowl lifting devices. Pall Advanta s for SUPRAcap 00 Modules This unique pressure vessel is designed specifically for the SUPRAcap 00 encapsulated module. This product utilizes the same filter media as standard SUPRAdisc and SUPRAdisc II modules, but is designed to protect operators from potentially dangerous fumes, catalysts, or activated carbon. The compartmentalized design of the pressure vessel minimizes product contact for easy cleaning. Additional Information about Depth Filter Modules Pall depth filter modules combine the advantages of conventional depth filter sheets with enclosed filters. We offer a completely scalable product line: Small-scale SUPRAcap 60 Depth Filter capsule, 6 cm (.8 in. ) Process development SUPRAcap 00 capsules, m (0.9.9 ft ), capable of being manifolded to increase surface area SUPRAdisc modules capable of holding an industry maximum of 5.0 m (5 ft ) per module. Each module is capable of holding media designed to filter products at a retention of µm with the lowest extractable concentrations in the industry. Refer to Pall brochure reference USD 6 Pall Filter Modules and Capsules with Seitz Depth Filter Sheets for additional details on this technology.. CLINICAL MANUFACTURING Pall Veladisc Filter s are low-cost housings that can be delivered quickly. They are capable of holding our SUPRAdisc I or II in. & 6 in. depth filter modules.. PROCESS SCALE Full scale manufacturing plants require customized depth filter housings. Pall Advanta s for SUPRAdisc Modules are capable of holding up to 00 m within a single housing.

4 Veladisc PED Filter Cost-effective Stainless Steel s Optimized for Biopharmaceutical Applications Veladisc PED-code Filter s are a low-cost depth filter solution for process development and optimization studies. The materials of construction and manufacturing techniques were selected to meet the requirements of PED 97//EC and the biopharmaceutical industry. Our housings have no product dead legs to avoid microbial contamination and maximize product recovery. Features and Benefits Each housing can be designed with the following optional features: Rathman bolting clamps or V-band clamp Peroxide-cured silicone or EPDM O-ring seals for complete chemical compatibility Flat gasket or double O-ring format to hold 8 mm ( in.) or 0 mm (6 in.) filter modules Split-dome design for height sensitive areas High quality surface finish of internal sets, electropolished Specifications Table : Design Details Materials of Construction Contact Surfaces AISI 6L Stainless Steel (DIN.0) () n-product Contact Surfaces AISI 0/0L Stainless Steel (DIN.0/.06) Adapter AISI 6L Stainless Steel (DIN.0) Design Specifications Surface Finish : typically Ra 0.6 µm ( µin.) electropolished External: Ra.6 µm (6 µin.) electropolished Pressure Rating () - to 8 barg (-.5 to 6 psig) for bolting clamp closure - to 5 barg (-.5 to 7 psig) for single V-band closure - to barg (-.5 to 58 psig) for double V-band closure Temperature Rating -0 to 50 C () Alternate materials available upon request () Safety pressure release valve must be installed in upstream pipeline to protect vessel

5 Veladisc PED Filter and and s Table : and s 8 mm ( in.) Module Figure : PED (for illustrative purposes only) per Stack 958 (8.0) 58 (50.0) 558 (.0) 858 (.8) 8 (.0) 8 (.0) 0 (7.0) 690 (7.0) 8 (0) 60 (6) 8 (0) 5 (55) 7 (59) 79 (7) D 558 (6.0) 58 (5.6) 8 (.0) 960 (8.0) 8 () (7) 87 (9) 858 (7.0) 58 (57.) 8 (.0) 0 (9.0) 05 (8) 0 (88) 9 (07) B Table : and s 8 mm ( in.) Module Modules per Stack E, mm (in.), A 67 (.) (.5) 6.0 (.).5 (9.9) 66 (5.0) 67 (5.5) 7.0 (5.) 6.0 (.) 905 (5.6) 905 (5.6) 8.0 (7.6) 7.5 (6.5) 7 (6.) 7 (6.) 9.0 (9.8) 9.0 (9.8) C Table : and s 0 mm (6 in.) Module per Stack E 987 (9.0) 57 (.0) 8 (.0) 0 (7.0) 66 (7) 7 (60) (9) 87 (5.0) 87 (.0) 8 (.0) 690 (7.0) (9) 6 (79) (7) 587 (6.0) 7 (6.0) 8 (.0) 960 (8.0) 6 () 7 (0) (9) 887 (7.0) 5 (59.0) 8 (.0) 0 (9.0) (56) 57 (6) (5) Table 5: and s 0 mm (6 in.) Module Modules per Stack E, mm (in.), 67 (.) (.5) 9.7 (.) 8.5 (8.7) 66 (5.0) 905 (5.6) 7 (6.) 67 (5.5) 905 (5.6) 7 (6.) 0.7 (.5).7 (5.7).7 (7.9) * Total weight does not include the weight of the internal set or modules designed to fit inside the housing.7 (5.7).9 (.8) 8. (9.8) A: Overall Height B: Height C: Height from Centerline to Floor D: Removal E: Height of and 5

6 Veladisc ASME Module s Cost-effective Stainless Steel s Pall Veladisc ASME Module s are a low-cost depth filter housing designed for clinical and small scale manufacture. Standard versions of the Veladisc line include to high modules in 8 mm ( in.) or 0 mm (6 in.) format for easy linear scale up of your operation. Our standard designs are available in exceptionally short lead times with a full documentation package. For assistance in selecting a housing to meet your process needs, including details about code certification, please contact our technical services department. Features and Benefits Split-dome design available for height-sensitive areas Peroxide-cured silicone or EPDM O-ring seals for complete chemical compatibility Flat gasket or double O-ring format to hold 8 mm ( in.) or 0 mm (6 in.) modules High-quality internal surface finish of internal sets, electropolished Specifications Table 6: Design Details Materials of Construction Contact Surfaces AISI 6L Stainless Steel (DIN.0) () n-product Contact Surfaces AISI 0/0L Stainless Steel (DIN.0/.06) Adapter AISI 6L Stainless Steel (DIN.0) Design Specifications Surface Finish : typically Ra 0.6 µm ( µin.) electropolished External: Ra.6 µm (6 µin.) electropolished Pressure Rating () - to 8 barg (-.5 to 6 psig) Temperature Rating -0 to 50 C () Alternate materials available upon request () Safety pressure release valve must be installed in upstream pipeline to protect vessel 6

7 Veladisc ASME Module s and and s per Stack Table 7: and s 8 mm ( in. ) Module Figure : ASME (for illustrative purposes only) 599 (.6) 859 (.8) 6 (8.9) 86 (9.) 70 (0.6) 70 (0.6) 0 (.7) 0 (.6) 5 (.0) 5 (9.) 8 (0) 8 (6) 56 () 7 (59) D 59 (5.6) 786 (0.9) 70 (0.6) 600 (.6) 6 (6.) (9) 88 (9) 59 (57.) 086 (.8) 70 (0.6) 880 (.6) 85 (.5) 5 (9) 0 (5) 759 (69.) 86 (5.6) 70 (0.6) 67 (6.0) (9.) 67 (8) (7) B Table 8: and s 8 mm ( in. ) Module Modules per Stack E, mm (in.), A 67 (.) (.5) 6.0 (.).5 (9.9) 66 (5.0) 67 (5.5) 7.0 (5.) 6.0 (.) INLET OUTLET 905 (5.6) 7 (6.) 905 (5.6) 7 (6.) 8.0 (7.6) 9.0 (9.8) 7.5 (6.5) 9.0 (9.8) C Table 9: and s 0 mm (6 in.) Module per Stack E 90 (5.6) 58 (0.) 70 (0.6) 0 (.6) 70 (8.5) 5 () 0 () 0 (7.) 88 (.) 70 (0.6) 600 (.6) 8 (.) 66 (5) 8 (60) 50 (59.) 8 (.0) 70 (0.6) 880 (.6) 59 (.0) 78 (7) 5 (98) 80 (80.0) 8 (55.8) 70 (0.6) (5.0) (56.6) 9 (0) 5 (0) Table 0: and s 0 mm (6 in.) Module Modules per Stack E, mm (in.), 67 (.) (.5) 9.7 (.) 8.5 (8.7) 66 (5.0) 905 (5.6) 7 (6.) 67 (5.5) 905 (5.6) 7 (6.) 0.7 (.5).7 (5.7).7 (7.9) * Total weight does not include the weight of the internal set or modules designed to fit inside the housing.7 (5.7).9 (.8) 8. (9.8) A: Overall Height B: Height C: Height from Centerline to Floor D: Removal E: Height of and 7

8 Pall Advanta s for SUPRAdisc Modules Designed Performance with Options for Customization The Pall Advanta for SUPRAdisc housing line is Pall's flagship housing technology for customized designed solutions. The manufacture of each housing begins with base engineering drawings modified to meet all your design and documentation requests. Features and Benefits Each housing can be designed with the following optional features: Validated for steam-in-place (SIP), cleaning-in-place (CIP)/riboflavin removal, and drainability per ASME BPE-005 Complete documentation package available on request, including Drainability certificate, Cleanability certificate, material certificates, vessel calculations, and quality plan Available in single and multi-round configurations All designs available with split dome for housing height restrictions Lifting devices available for both housing bowl and internal sets Specifications Table : Design Details Materials of Construction Contact Surfaces AISI 6L Stainless Steel (DIN.0) () n-product Contact Surfaces AISI 0/0L Stainless Steel (DIN.0/.06) Adaptor AISI 6L Stainless Steel (DIN.0), Nitronic 60 Design Specifications Surface Finish : Ra 0. µm (5 µin.) electropolished External: Ra 0.8 µm ( µin.) electropolished Pressure Rating () -.5 to 50 psig (- to 0 barg) Temperature Rating -0 to 50 C () Alternate materials available upon request () Safety pressure release valve must be installed in upstream pipeline to protect vessel 8

9 Pall Advanta for SUPRAdisc Modules and and s per stack Table : and s 8 mm ( in. ) Module Figure : SUPRAdisc Module (for illustrative purposes only) 99 (7.0) 69 (50.0) 5 (0.) 8 (.) 7 (0.7) 7 (0.7) 80 (5.0) 70 (8.0) (8.8) 60 (5.9).5 (5.) 9.5 (.9) 56 (.) 6 (0.8) D 599 (6.0) 7 (6.) 7 (0.7) 00 (0.95) 87.5 (.) 7.5 (60.5) 7 (58.) 99 (76.0) 50 (59.) 7 (0.7) 80 (5.).5 (0.5) 5.5 (78.) 80 (76) Table : and s 8 mm ( in. ) Module Modules per stack E, mm (in.) 67 (.) (.5) 6.0 (.),.5 (9.9) B 68 (5.) 67 (5.5) 7.0 (5.) 6.0 (.) 905 (5.6) 7 (6.) 905 (5.6) 7 (6.) 8.0 (7.6) 9.0 (9.8) 7.5 (6.5) 9.0 (9.8) A Table : and s 0 mm (6 in.) Module per Stack 95 (7.) 5 (9.) 5 (0.) 8 (.) 57 (0.) 57 (0.) 80 (5.0) 70 (8.0) 6 (6.5) (9.5) 8 (8.6) 5 (6.6) 6 (55.) (88.) C 6 (6.) 7 (6.) 57 (0.) 00 (.0) 6 () 68 (9.6) 6 (.) 9 (76.) 50 (59.) 57 (0.) 80 (5.) 5 (57) 8 (80.) 60 (5) Table 5: and s 0 mm (6 in.) Module Modules per Stack E, mm (in.) 67 (.) (.5), 9.7 (.) 8.5 (8.7) E 68 (5.) 67 (5.5) 0.7 (.5).7 (5.7) 905 (5.6) 905 (5.6).7 (5.7).9 (.8) 7 (6.) 7 (6.).7 (7.9) 8. (9.8) Table 6: and s Three-round Module 58 (6.) 789 (.) 8 (7.) 890 (5.0) 86 (0) 08 (677.6) 80 (86) 886 (7.) 09 (.) 8 (7.) 95 (7.) 568 (50) 8 (8.8) 906 (99.) 9 (86.) 99 (55.) 8 (7.) 500 (59.) 75 (99) 60 (0) 98 (60.) Table 7: and s Four and Five-round Module s 56 (5.) 66 (65.) 966 (77.) 687 (7.0) 99 (9.) 97 (5.) 0 (.) 0 (.) 0 (.) 890 (5.0) 95 (7.) 500 (59.) 70 (95.5) 080 (85.) 0 (75.) 6 (5.6) 767 (69.0) 800 (0.6) * Total weight does not include the weight of the internal set or modules designed to fit inside the housing 807 (98.7) 900 (88.8) 000 (09.) A: Overall Height B: Height C: Height from Centerline to Floor D: Removal E: Height of and 9

10 Pall Advanta s for SUPRAcap 00 Modules Unique Disposable Solution for Critical API and Biopharmaceutical Applications Pall Advanta s for SUPRAcap 00 Modules are the only housings in the industry capable of holding encapsulated process scale modules with an identical flow path to traditional depth filter modules. Our encapsulated modules are offered in all of our media grades; therefore, selection of the appropriate filter area and media can be determined from previous filterability studies, without the need to revalidate a specific type or style of module. Features and Benefits The combination of full encapsulation of the filter module and minimized contact with stainless steel surfaces yields significant reduction in cleaning costs Our capsule dramatically reduces void volume in comparison to traditional modules, and housing hold up volume is less than standard stainless steel housing cross-contamination risks All components have material certification te: For additional information on SUPRAcap 00 Modules, please request Pall brochure USD 95, SUPRAcap 00 Encapsulated Depth Filter Modules from your local Pall representative Specifications Table 8: Design Details Materials of Construction Contact Surfaces AISI 6L Stainless Steel (DIN.0) () n-product Contact Surfaces AISI 6L Stainless Steel (DIN.0) Adapter Acetal Copolymer, 6L Stainless Steel or Hastelloy C Design Specifications Surface Finish (product-wetted parts): typically Ra 0. µm (5 µin.) electropolished External: Ra 0.8 µm ( µin.) electropolished Pressure Rating () - to 8 barg (-.5 to 6 psig) Temperature Rating -0 to 50 C () Alternate materials available upon request () Safety pressure release valve must be installed in upstream pipeline to protect vessel 0

11 Pall Advanta s for SUPRAcap 00 Modules and and s Table 9: and s: PED Versions 8 mm ( in. ) Module per Stack Bowl Figure : SUPRAcap 00 Module (for illustrative purposes only) 75 (6.) 8 (9.0) - 8 (7.) 70 (5.) 50 (60.6) 87 (.) - 5 () 90 (98.) 905 (75.0) 8 (9.0) 75 (9.) 79 (0.9) 5 (5.5) 70 (89.) 87 (.) 75 (9.) 0 (7.5) 5 (97.6) B Table 0: and s: ASME Versions 8 mm ( in. ) Module per Stack Bowl A C 5 (9.) 50 (0.9) - 8 (7.) 95 (09.) 5 (60.7) 8 (.8) - 5 () 5 (5.5) 979 (77.9) 67 (8.) 70 (8.7) 79 (0.9) 0 (08.6) (9.) 8 (.8) 70 (8.7) 0 (7.5) 60 (5.7) * Total weight does not include the weight of the internal set or modules designed to fit inside the housing A: Overall Height B: Height C: Extension Height

12 Pall Advanta for SUPRAdisc Module designed to hold twenty, 6 in. Modules.

13 Ordering Information Pall Part : Veladisc PED Depth Filter P Module Diameter Modules Closure Type Adapter Inlet / Outlet mm ( in.) 0 mm (6 in.) C H V-band Clamp Screws TC00 () DN00 () DN0 Sanitary Clamp to DIN676 DN0 Sanitary Clamp to DIN85 TC050 () DN50 Sanitary Clamp to DIN676 DN050 () DN50 Sanitary Clamp to DIN85 Sample Part : P8 0C88TC00 Pall Part : Veladisc ASME Depth Filter P TC -CMV Module Diameter Modules Closure Type Adapter Inlet / Outlet 6 8 mm ( in.) 0 mm (6 in.) E Swing Bolt Closure D in. Sanitary Clamp Sample Part : P-0E88TC.5D-CMV Pall Part : Pall Advanta for SUPRAdisc Modules ADC Design Basis Module Diameter Modules Adapter Inlet / Outlet Connections A D ASME VIII Div, U Stamp PED 97//EC CAT III 6 () 8 mm ( in.) 0 mm (6 in.) G F R ne L () () in. Sanitary Clamp in. Sanitary Clamp Vent Drain Gasket Material S N in. gauge port with in. side vent ne D N in. Sanitary Clamp ne H J H H Peroxide cured silicone Ethylene Propylene Platinum cured silicone FEP encapsulated Viton Sample Part : ADCAGLSDH Pall Part : Pall Advanta for SUPRAcap Modules ACT G N Module Diameter Modules Inlet / Outlet Drain Gasket Material A D ASME VIII Div, U Stamp PED 97//EC CAT III T L DN0/ DIN 676 in. Sanitary Clamp (ISO 07/ BS85) D X in. Sanitary Clamp (ISO 07/ BS85) DN0 (DIN 676) H H FEP encapsulated Viton Peroxide cured silicone N ne Sample Part : ACTAGLNDH () 6 for -round, 6 for -round, 56 for 5-round. () for 8 mm ( in.) modules only. () for 0 mm (6 in.) modules only. te: Module height varies from 7.8 mm (0.7 in.) to.7 mm (. in.) in height depending on adapter style and media type. bowl height will not vary depending on module selected.ordering information for multi-round vessels is available upon request. Please contact your Pall representative for details.

14 New York - USA phone fax biotech@pall.com Portsmouth - Europe + (0) 90 0 phone + (0) fax BioPharmUK@europe.pall.com Visit us on the web at Pall Corporation has offices and plants throughout the world in locations including: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, rway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, the United States and Venezuela. Distributors are located in all major industrial areas of the world. Because of developments in technology these data or procedures may be subject to change., Pall, Pall Advanta, SUPRAcap, SUPRAdisc and Seitz are trademarks of Pall Corporation. Filtration. Separation. Solution. is a service mark of Pall Corporation. Part s quoted above are protected by the Copyright of Pall Corporation. indicates a trademark registered in the USA. 007, Pall Corporation. PELEH/MG/0.07